Low profile stepped delivery system

ABSTRACT

A low profile stepped delivery system for retracting trigger wires from a prosthesis to release the prosthesis from a delivery device. A rod is disposed within an axial bore of a handle. The rod has a first longitudinal surface and a second longitudinal surface. A first engagement mechanism is disposed on the first longitudinal surface and a second engagement mechanism disposed on the second longitudinal surface. A wire coiling assembly is disposed at an end of the of the handle and comprises a first rotary gear that is adapted to be rotated by the first engagement mechanism, a second rotary gear that is adapted to be rotated by the second engagement mechanism, a first wire spool that is coupled to a rotation of the first rotary gear, and a second wire spool that is coupled to the rotation of second rotary gear. The first wire spool is configured to secure a first trigger wire and the second wire spool is configured to secure a second trigger wire.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a non-provisional application which claims priorityto U.S. Provisional Application No. 61/719,599 filed Oct. 29, 2012, thecontents of which is incorporated in its entirety.

BACKGROUND

This invention relates to medical devices and, in particular, todevices, systems, and methods for actuating a plurality of trigger wiresfor delivery of an endoluminal prosthesis, such as a stent graftdelivered in a body lumen.

Deploying an endoluminal prosthesis into a vessel of a patient from alocation outside the body is generally known. An endoluminal prosthesis,such as a stent or stent graft, is typically introduced into a vessel ina radially constrained state. Once the endoluminal prosthesis ispositioned, it can then be deployed within the vessel by actuation of atrigger wire system.

An endoluminal prosthesis may be either self-expanding orballoon-expandable, or it can have characteristics of both types. Aself-expanding endoluminal prosthesis may be delivered to a target sitein a compressed configuration and subsequently expanded by removing adelivery sheath, removing trigger wires, and/or releasing diameterreducing ties. With a self-expanding endoluminal prosthesis, theendoluminal prosthesis expands primarily based on its own expansiveforce without the need for further mechanical expansion. In anendoluminal prosthesis made of a shape-memory alloy such as nitinol, theshape-memory alloy may be employed to cause the endoluminal prosthesisto return to a predetermined configuration upon removal of the sheath orother device maintaining the endoluminal prosthesis in itspre-deployment configuration.

When trigger wires are used as a deployment control mechanism for astent graft, the trigger wires may releasably couple the proximal and/ordistal ends of a stent to a delivery catheter. For example, one or moretrigger wires may be used to retain a stent graft at one or both ends toa delivery device. For example, one or more trigger wires may be loopedthrough a portion of a stent or the graft at one or both ends of theprosthesis prosthesis. For example, a stent graft may have proximaland/distal stents having apices. The trigger wires may be disposedthrough, and pull upon, one or more of the apices to pull the stentclosely against the delivery catheter. Alternatively, the trigger wiresmay run through one or more sutures which are attached to one or moreapices of the stent, such as disclosed and shown in U.S. Publication No.2008/0140178, and in particular FIGS. 3-8 and accompanying text, whichdisclosure is incorporated by reference in its entirety.

An endoluminal prosthesis is typically introduced into a vessel via adelivery device. Such a delivery device may include a cover or sheaththat covers the endoluminal prosthesis. The sheath covering theendoluminal prosthesis is then manipulated within the vessel to a targetlocation for deployment. The sheath is retracted such that it no longercovers the endoluminal prosthesis, allowing the endoluminal prosthesisto expand. The sheath is typically retracted by manually pulling thesheath back in a distal direction. The sheath may also be retractedthrough the use of at least one trigger wire. The trigger wire may pullon the sheath.

Trigger wires extending from a distal end of the delivery device to theprosthesis may then be retracted by simply pulling on them to releasethe ends of the prosthesis from the delivery device. The trigger wirescan be manipulated from the distal end of the delivery device.

SUMMARY

The present disclosure provides a system to actuate trigger wires in adelivery device. The system includes a handle having a proximal end, adistal end, and an axial bore through the handle. A rod is slideablydisposed within the axial bore. The rod has a proximal end, a distalend, a first longitudinal surface, and a second longitudinal surface. Afirst engagement mechanism is disposed on the first longitudinal surfaceand a second engagement mechanism is disposed on the second longitudinalsurface. A wire coiling assembly is disposed at the distal end of the ofthe handle and comprises a first rotary gear that is adapted to berotated by the first engagement mechanism, a second rotary gear that isadapted to be rotated by the second engagement mechanism, a first wirespool that is coupled to a rotation of the first rotary gear, and asecond wire spool that is coupled to the rotation of second rotary gear.The first wire spool is configured to secure a first trigger wire andthe second wire spool is configured to secure a second trigger wire.

In another example, a system for delivering an endoluminal prosthesis isdescribed. The system includes a handle having a handle proximal end, ahandle distal end, and a longitudinal bore. An elongated tubular memberis secured to the handle. The elongated tubular member has a tubularmember proximal end, a tubular member distal end, and at least one lumenbetween the tubular member proximal end and the tubular member distalend. A sheath is disposed at the tubular member proximal end and thesheath is configured to slide about the elongated tubular member in alongitude direction. An endoluminal prosthesis is disposed at thetubular member proximal end and the endoluminal prosthesis is radiallyconstrained by the sheath. A first trigger wire extends from the handlethrough the at least one lumen to the proximal end of the elongatedtubular member. The first trigger wire retains the proximal end of theprosthesis on the delivery device. A second trigger wire may extend fromthe handle through the at least one lumen to the distal end of theelongated tubular member. The second trigger wire retains the distal endof the endoluminal prosthesis on the delivery device. A wire coilingassembly is disposed in the distal end of the handle. The wire coilingassembly includes a rod having a first surface having a first pluralityof teeth and a second surface having a second plurality of teeth, and acoiling mechanism comprising a first gear configured to engage the firstplurality of teeth, a second gear configured to engage the secondplurality of teeth, a first spool securing the first trigger wire andcoupled to the rotation of the first gear, and a second spool securingthe second trigger wire and coupled to the rotation of the second gear.

A toothed rod, usable in a rack and pinion assembly, may be used in theendoluminal prosthetic deployment system disclosed. The rod has a distalhandle. Between the distal end and the proximal end, a first surface isdisposed. The first surface has a first portion disposed proximate theproximal end with teeth and a first smooth portion disposed proximatethe distal end. A second surface is disposed between the distal end andthe proximal end. The second surface has a second smooth portiondisposed proximate the distal end, a third smooth portion disposedproximate the proximal end, and a second portion having teeth disposedbetween the second smooth portion and the third smooth portion. Thetrigger wire system may further have one or more trigger wires attachedto the sheath and adapted to slide the sheath relative to theendoluminal prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of theone or more present inventions, reference to specific embodimentsthereof are illustrated in the appended drawings. The drawings areexemplary are therefore not to be considered limiting.

FIG. 1 shows an example of a handle of a delivery device for anendoluminal prosthesis.

FIG. 2 shows the handle of FIG. 1 with a portion of a trigger wireactuation mechanism disposed within the lumen of the handle.

FIG. 3 shows an exemplary rod or rack mechanism of a trigger wireactuation mechanism.

FIG. 4 shows an exemplary handle with an exemplary trigger wireactuation mechanism before the trigger wires have been released.

FIG. 5 shows the mechanism of FIG. 4 where at least one of the triggerwires has been released.

FIG. 6 shows an alternative trigger wire actuation mechanism.

FIG. 7 shows another alternative trigger wire actuation mechanism.

FIG. 8 shows a perspective view of an exemplary delivery device.

FIG. 9 shows a perspective view of the device of FIG. 8 where the sheathhas been withdrawn from the prosthesis and the trigger wires retracted.

FIG. 10 shows a proximal end of a delivery device.

FIG. 11 shows another view of a proximal end of a delivery device.

FIG. 12 shows a detailed view of a distal attachment mechanism for adistal trigger wire.

FIG. 13 is another view of the mechanism of FIG. 12.

DETAILED DESCRIPTION

In the present application, the term “proximal” refers to a directionthat is generally closest to the heart during a medical procedure, whilethe term “distal” refers to a direction that is furthest from the heartduring a medical procedure. To further clarify, the proximal end of adelivery device is that end that is disposed within the patient and thedistal end is that end outside of the patient during a procedure.

The term “prosthesis” means any device, object, or structure thatsupports, repairs, or replaces, or is configured to support, repair, orreplace a body part or a function of that body part. It can also mean adevice that enhances or adds functionality to a physiological system.Examples of prostheses include stents, stent grafts, vessel occlusiondevices, vena cava filters, and the like.

The term “stent” means any device or structure that provides, or isconfigured to provide, rigidity, expansion force, or support to a bodypart (e.g., a diseased, damaged, or otherwise compromised body lumen). Astent may comprise any suitable material, including, but not limited to,biocompatible metals and plastics. Examples of suitable materialsinclude metals such as stainless steel and NITINOL, and plastics such aspolyethylene terephthalate (“PET”), polytetrafluoroethylene (“PTFE”) andpolyurethane.

A stent may be “expandable,” that is, it may be capable of beingexpanded from a constricted configuration to an expanded configuration.A stent may be self-expanding and expand by virtue of its ownresilience. Alternatively, a stent may be pressure-expandable and expandonly upon the application of an external force. In addition, a stent maybe expandable upon application of heat, such as when exposed to bodytemperature. An example of a self-expanding stent is the Z-STENT®, whichis available from Cook Incorporated, Bloomington, Ind., USA.

The term “lumen” describes a cavity or channel within a tube or atubular body, such as body vessel. The term “endoluminal” means within alumen, and can refer to objects that are found or that can be placedwithin a lumen, or methods or processes that occur within a lumen. An“endoluminal prosthesis” is thus a prosthesis that is found, or that canbe placed, within a lumen. Examples of endoluminal prostheses include,but are not limited to, stents, grafts, stent grafts, venous or aortalvalves, and vena cava filters. An endoluminal prosthesis may begenerally tubular and comprise one or more lumens. Examples of tubularprostheses include straight, branched, and bifurcated prostheses.

Described is a handle for a trigger wire actuation mechanism for aprosthesis delivery device. In operation, a proximal end of the deliverydevice is introduced into a patient's vessel and guided to a deliverylocation. The distal end remains external to the patient and provides acontrol handle for the delivery device. As described further below, thedelivery device has a prosthesis retained on the delivery device by oneor more trigger wires and held, prior to delivery, in a compressedcondition by a retractable sheath. The prosthesis may be a stent orstent-graft or other medical device for which trigger wires are used toretain the device on and release it from the delivery device. Exemplaryprostheses are expandable stents and stent grafts.

FIG. 1 shows a portion of an exemplary delivery device 100, and inparticular a delivery device handle 102. The handle 102 is configured tobe disposed at or near the distal end (not shown) of the delivery device100. The handle has a proximal end 104, a distal end 106 and actuationknob or handle 110. A trigger wire actuation mechanism housing 108 isdisposed at the distal end of the handle 102 The handle 102 has anelongated member 111 having at least one lumen 113 between the proximalend 104 of the handle 102 and the distal end 106 of the handle 102. Thehousing 108 may have a diameter of 0.5 to 1.5 inches, preferably about 1inch, and a length of 0.2 to 1 inch, preferably about 0.5 inches. Theactuation knob/handle 110 is about 0.1 to 0.3 inches in diameter andpreferably about 0.2 inches in diameter.

As shown in FIG. 2, a track system, such as an elongate trigger wireactuation rod 112 is disposed in the lumen 113 of the handle 102. Therod 112 extends substantially for the length of the lumen of the handle102. As shown, the rod 112 may be in the form of a rack, which isconfigured to engage one or more gears (not shown in FIGS. 1 and 2). Therod 112 has an upper surface 114, a lower surface 116, a proximal region118, a distal region 120, a proximal end 122 including a proximal hub123, and a distal end portion 124. The rod 112, in an exemplary handle,may be 2 to 4 inches long and preferably about 3 inches long. The rod112 may have a diameter of 0.2 to 0.5 inches, and preferably about 0.35inches. The rod 112 may have teeth 126, 128 on either or both of theupper surface 114 and the lower surface 116.

As shown in FIG. 3, the rod 112 may have upper teeth 126 and lower teeth128. In this example, the upper teeth 126 extend along the upper surface114 only in the area of the proximal region 118 and the lower teeth 128extend along the lower surface 116 only in the area of the distal region120, such that the distal most upper tooth 126′ ends approximately wherethe proximal most lower tooth 128′ begins. There may be some overlap ofthese regions. Although the rod 112 is shown with the upper teeth 126 inthe proximal region 118 and the lower teeth 128 in the distal region120, the opposite configuration may also be used. The length of each ofthe proximal 118 and distal 120 regions may each be 2-4 cm long, andpreferably about 3 cm long. The distal end region 124 preferably has noteeth and is of sufficient length to extend through the housing 108 andout the distal end 106 of the handle.

FIGS. 4 and 5 show an exemplary handle for a prosthesis delivery devicehaving a track and gear (for example, a rack and pinion) trigger wireactuation system. The gears and track may be of any suitable material,but are preferably formed of a very hard plastic such as Delrin. As setforth above, prosthesis delivery systems may use one or more triggerwires to retain either or both the proximal and distal ends of theprosthesis to the delivery system until it is desirable to release theprosthesis from the delivery system. In one example, a proximal triggerwire system, with one or more trigger wires, retains the proximal end ofthe prosthesis to a proximal retention region or point on the deliverysystem, and a separate distal trigger wire system, with one or moretrigger wires, retains the distal end of the prosthesis to a distalretention region or point on the delivery system. In some examples, itmay be desirable to retain a single end of the prosthesis, such as shownin U.S. Publication No. 2006/0142836, which disclosure is incorporatedby reference herein in its entirety. In other examples, one triggerwire, or one set of trigger wires may be used to retain both ends of theprosthesis, such as shown in U.S. Publication No. 2008/0140178, whichdisclosure is incorporated by reference herein in its entirety.

The trigger wire or wires may, for example, engage the graft material ofa stent graft prosthesis at either or both ends either directly orindirectly or engage proximal most and distal most stents on theprosthesis either directly or indirectly. For example, one or moretrigger wires may directly engage stent ends or apices and draw theminward into the delivery device such as shown in FIG. 14 of U.S.Publication No. 2006/0142836, which disclosure is incorporated byreference herein in its entirety, or may engage threads or sutures thatengage the stent end or apices, such as shown in FIGS. 5-8 of U.S.Publication No. 2008/0140178 and FIGS. 14-17 of U.S. Publication No.2006/0142836, which disclosure is incorporated by reference herein inits entirety. As set forth above, one trigger wire may be used for each,or either end, such as that shown in FIG. 13 of U.S. Publication No.2006/0142836, which disclosure is incorporated by reference herein inits entirety, or multiple trigger wires such as FIG. 12 of U.S.Publication No. 2006/0142836, which disclosure is incorporated byreference herein in its entirety.

FIGS. 4 and 5 show an exemplary handle for a prosthesis delivery devicehaving a track and gear (for example, a rack and pinion) trigger wireactuation system. Handle 200 is configured to be located at or near adistal end of a delivery system. Handle 200 has a proximal end 202, adistal end 204, a trigger wire actuation mechanism housing 206, and anelongate proximal portion 208. Elongate proximal portion 208 has acentral lumen 210 extending therethrough. Elongate proximal portion 208may also have a separate track or lumen 212 for one or more guidewires214, 216. Elongate proximal portion 208 may be cylindrical and mayinclude a grip, such as that shown in FIG. 6, and also may include agreater diameter proximal end, such as that shown in FIG. 6. Theincreased diameter provides a gripping point for a user. The proximalend 202 of the handle 200 is sized and shaped to be attached to adelivery device. Such attachment may include a threaded portion, a pressfit attachment, a plastic weld, a barb, or other type of attachment asknown in the art. Disposed within the central lumen 210 is track/rod,such as that described above with respect to FIGS. 2 and 3.

Shown in the example of FIGS. 4 and 5, disposed within the trigger wireactuation mechanism housing 206 is a trigger wire winding or coilingassembly 220. The housing 206 may have a diameter greater than adiameter elongate proximal portion 208 and houses the mechanicalcomponents of the trigger wire coiling assembly 220, described furtherbelow. The rod 218 is disposed longitudinally within central lumen 210and extends past the wire coiling assembly 220 and out of the distal end204 of the handle 200. The distal end of the rod 218 has a grippinghandle 222 for manipulating the rod 218.

The mechanical components contained within the wire coiling assembly 220are configured to convert a linear motion of the rod 218 into a windingaction of the trigger wires 214, 216. These mechanical componentsprovide a mechanical advantage allowing the trigger wires 214, 216 torelease one or both ends of the prosthesis with less force than isotherwise possible by mere pulling on the trigger wires. In oneembodiment, a three to one mechanical advantage gives an optimumcombination of travel of the rod 218 and reduced force for retraction ofthe trigger wires and full deployment of the prosthesis. In anotherexample, one of the trigger wire mechanisms, rather than retractingtrigger wire, may be used to retract the retractable sheath that isdisposed over the prosthesis. In this case, one or more trigger wiresare attached to the sheath and retraction of the trigger wires causesdistal retraction of the sheath from over a prosthesis to expose theprosthesis.

FIGS. 4 and 5 show one exemplary trigger wire actuation assembly. Asshown in these FIGS. 4 and 5 and shown and described with regard toFIGS. 2 and 3, the rod 218 has a proximal end 224, a distal end 226, andtwo opposing sides 228, 230 at two opposing angular orientations. Theproximal end 224 remains disposed within central lumen 210 of thehandle. The two sides 228, 230 may be an upper surface and a lowersurface, respectively, of the rod 218, or may be any substantiallyopposing side surfaces. The upper surface 228 of the rod 218 has a rowof gear teeth 232 and the bottom surface 230 of the rod 218 has anotherrow of gear teeth 234. The gear teeth 232, 234 are sized and shaped tointeract with a respective drive gear 236, 238. In the embodiment ofFIGS. 4 and 5, the gear teeth 232, 234 are the same size and shape oneach surface but need not be.

As shown in FIGS. 2, 3, 4 and 5, the upper surface gear teeth 232 aredisposed on a proximal portion (FIG. 3, numeral 118) of the rod 218 andthe lower surface gear teeth 234 are disposed on a distal portion (FIG.3, numeral 120) of the rod 218. As shown, the upper surface 228 has asmooth or blank portion 235 corresponding to the toothed lower surfaceand the lower surface 230 has a smooth or blank portion 237corresponding with the toothed upper surface. The toothed regions may beof the same length, or may be of different lengths depending on theapplication. A region 240 of the rod 218 distal to the distal portion,and ending in the grip 222 has smooth or blank upper and lower surfacesso that this region does not engage the gear teeth. As shown, thisregion 240 must be of sufficient length to extend through the gears andout of the housing. The proximal end of the rod may be provided with ahub or stop 242 to prevent the rod 218 from being fully removed from thehandle. In other instances, the rod 218 may not have a stop and may becompletely removed.

The mechanical components of the housing 220 may include two sets ofgears including a set of drive gears 236, 238 and a set of spool gears244, 246. Each set of gears corresponds to one of the rod surfaces. Thesets of gears are selected to provide a desired mechanical advantage. Inthe example of FIGS. 4 and 5, the spool gears 244, 246 have a radiusthree times greater than a radius of the drive gears 236, 238 resultingin a 3 to 1 mechanical advantage. The drive gears translate thelongitudinal movement of the rod out to torque, which is then translatedto the larger spool gear with a 3:1 ratio to the drive gear. The spoolgear winds the trigger wire with three times the torque of the drivegear. In other configurations, the gear ratio may be different and maybe different for each set of gears. For example the gear ratio may be2:1 to 4:1.

As shown in FIGS. 4 and 5, trigger wires 214, 216 (or sets of triggerwires) are wound onto their respective spool gear 244, 246. A largemetal pin 248 at the center of each spool gear will attach the wires tothe spool gear.

The gears are considered to be coupled in rotation if the rotation ofone gear causes a rotation in a corresponding gear. For example, theperimeter of the gears may interact coupling their rotation, or theycould be coupled about a common axis and rotate at the same angularvelocity. FIGS. 4 and 5 illustrate gears 236, 238, 244, 246 that haveparallel axes of rotation, with each axis of rotation beingperpendicular to the longitudinal axis of the rod 218.

FIG. 7 illustrates another example of a handle 300. As with FIGS. 4 and5, handle 300 has and elongate proximal portion 302, a central lumen304, at least one trigger wire lumen 306, trigger wires 308, 310, gearhousing 312, and rod 314. In the example of FIG. 7, a wire coilingassembly 318 is illustrated where the sets of gears include drivinggears 320, 322 and spool gears 324, 326, which are beveled andorientated such that their respective axis of rotation are perpendicularto one another. Such a configuration has the added advantage ofmaintaining a lower profile than the configuration of FIGS. 4 and 5,because the larger gear is horizontal and presents a narrow profile.Further the bevel gears can be used to change directions.

As shown in FIG. 6, a wire coiling assembly 400 is illustrated in whichdriving gears 402, 404 are integrated with spools 406, 408. Themechanical advantage of the system can be adjusted by varying the ratioof the radius of the driving gears 402, 404 to the radius of the spool406, 408. As shown in FIG. 6, the proximal end 410 of the handle 412 mayhave a larger diameter than the elongate portion 414 of the handle toprovide a gripping point. Although not shown in FIG. 6, as shown inFIGS. 4, 5 and 7, one or more separate lumens may be provided for thetrigger wires to prevent tangling with the rod 416.

A shown in the FIGS. 6 AND 7, as discussed above, the rod has a row ofteeth on one surface and a row of teeth on a second surface. The row ofthe teeth on the first surface starts at or near the proximal end of therod and extends to an intermediate point on the rod and the second rowof teeth extends the intermediate point on the rod toward the distalend. Distally beyond the second row of teeth, the rod has a smoothsurface that does not engage with the drive gear.

Operation of the trigger wire actuation system will now be describedwith reference to FIGS. 4, 5, 8, and 9. In FIGS. 8 and 9, a prosthesisdelivery system 500 is shown. A prosthesis 502 is disposed on the deviceand covered initially by sheath 504. The prosthesis may have one or morestents such as a proximal end stent 506 and a distal end stent 508disposed on and/or in a tube of graft material 509. The stents may haveapices 510 as shown in FIG. 9. The sheath 504 is retractable from theprosthesis and may be connected to handle 512. Upon retraction of thesheath 504, by either moving the sheath 504 manually distally oradvancing the rod 514 in the direction of the arrow in FIG. 9 to retracta trigger wire and coil it onto its respective spool gear, theprosthesis is exposed and allowed to at least partially expand.

In either case, once the sheath 504 is withdrawn, one or both ends ofthe prosthesis remain retained on the device by one or more trigger wireretention systems. For example, trigger wires 518, 520, which extendfrom the housing 520 to may be attached each to one end of theprosthesis to retain it onto the delivery device until the ends arereleased. As shown in FIG. 9, trigger wire 518 is attached to theproximal end 519 of the prosthesis 502 at attachment point 522 andtrigger wire 520 is attached to the distal end 521 of the prosthesis 502at attachment point 524. To release the ends of the prosthesis, thehandle 516 of the rod is pulled distally and as the first row of teethengages is respective drive gear, rotates the drive gear, which rotatesit's corresponding spool gear to wind the trigger wire 518, 520 onto thespool gear (not shown) and release the trigger wire from its respectiveend of the prosthesis. Each spool gear may have a large center pin towhich the trigger wire is attached and onto which it winds. As the rod514 is pulled further, the second drive gear engages the second row ofteeth, rotates the second drive gear and the corresponding spool gear towind the second trigger wire onto the second spool gear therebyreleasing the second trigger wire from its respective end of theprosthesis.

Referring again to FIGS. 4 and 5, the rod 218 is initially positionedinside the handle 200 with the distal end of the rod 218 near the distalportion end of the handle 200 and the proximal end of the rod 218 nearthe proximal end of the handle 200. Thus, when the rod 218 is moved fromits initial position in a distal direction as indicated by the arrow inFIG. 5, the drive gear 236 corresponding to the upper surface 228 doesnot rotate until the row of teeth 232 engages the drive gear 236. Thisallows the rod 218 to be moved axially initially without rotating thedrive gear 236. After the rod 218 has moved a predetermined distance,the row of teeth 232 will engage the drive gear 236 causing it to rotatewith further movement of the rod 218.

On the lower surface 230 of the rod 218, the row of teeth 234 startsnear the distal portion of the rod and extend towards the center of therod 218. The proximal portion of the rod has a smooth surface such thatit will not drive its corresponding drive gear 238. When the rod 218 isinitially moved in the distal direction, the row of teeth 234 on thelower surface 230 of the rod 218 drive the corresponding drive gear 238before the row of teeth 232 on the upper side 228 drive thecorresponding drive gear 236. The lengths of the rows of teeth may bethe same or different depending on the requirements of the deliverydevice. For example, if a delivery mechanism requires a long length oftravel for one trigger wire versus another, the length of thecorresponding row of teeth is extended. Another example of a deliverydevice that requires a longer amount of travel is a delivery device witha sheath that is retracted by one of the trigger wires. Alternatively,if the delivery device does not require a long travel, the length of therow of teeth may be shorter.

As set forth above, the rows of teeth may be such that they do notoverlap and one row starts where the other ends. In other examples, therows may overlap at some point such that both rows drive theircorresponding gears simultaneously for some length. It is also possiblethat a portion of the rod may have no geared teeth between the finish ofone row and the start of the other such that no corresponding drivegears are driven for that portion of the rod. By varying the startingand ending position of the rows of teeth, the trigger wires can have astaggered activation with one movement of the rod. Although the examplesdescribed are directed to pulling the rod distally, devices where therod is pushed into the device, thereby rotating gear sets and retractingtrigger wires are also contemplated.

As shown in the FIGS. 3-7, the rod has an upper surface and a lowersurface at opposite angular orientations, but other configurations arecontemplated. For example, the rod may have a polygonal cross sectionwith a different track on each side of the polygon. A rod having atriangular cross section would have three longitudinal surfaces at threedifferent angular orientations that could have three separate rows ofteeth. By varying the relative positioning of the rows of teeth, thetriggering sequence of the trigger wires can be easily controlled.

The rod may have an engagement mechanism other than geared teeth. Forexample, the rod may have a flat surface with a friction enhancement forinteracting with a smooth wheel. In some embodiments, the set of gearsmay be toothless, in which friction between the gears causes rotation,and in still other embodiments, the sets of gears may have a pulley typearrangement.

In other arrangements, the rod has a third longitudinal surface disposedat a third angular orientation between the proximal rod end and thedistal rod end, the third longitudinal surface having a third engagementmechanism disposed on the third longitudinal surface. In thisarrangement, the wire coiling assembly further comprises a third rotarygear linked to an axial movement of the third engagement mechanism and athird wire spool coupled to the rotation of the third rotary gear, wherethe third wire spool is secured to a third trigger wire which is woundonto the third wire spool.

In one preferred device, as the rod is pulled distally, a first triggerwire or set of trigger wires is retracted and wound on to its spooluntil the proximal end of the trigger wire disengages from the proximalend of a restrained prosthesis, thereby releasing the proximal end ofthe prosthesis from the delivery device. Thereafter, as the rod ispulled further distally, a second trigger wire or set of trigger wiresis retracted and wound on to its spool until the proximal end of thesecond trigger wire disengages from the distal end of the graft, therebyreleasing the distal end of the prosthesis from the delivery device. Inanother preferred device, the trigger wires are attached such that thedistal end of the prosthesis is released first by retraction of thefirst trigger wire or set of trigger wires and the proximal end of theprosthesis is thereafter released by retraction of the second triggerwire or set of trigger wires.

FIGS. 10-13, show one example of how the trigger wires may engage aprosthesis 600 at the proximal end 602 of delivery device 604 having ahandle and trigger wire mechanism as previously described (not shown).As shown, delivery device proximal end 602, has a pusher 606, and innercannula 608, a tapered nose cone dilator 610. Prosthesis 600 is disposedon the delivery device 604 and has a distal end 612 and a proximal end614. The inner cannula 608 is at least partially disposed through alumen 616 of the pusher 606. As shown in this example, pusher 606 has apair of distal bores 617, 618 that extend from the lumen 616 and throughthe wall of the pusher 606. A pair of proximal bores 620, 622 extendfrom a lumen at the proximal end and through the wall of the proximalend of the delivery device.

One or more trigger wires 624, 626 extends from the handle mechanism asdescribed above and through the lumen 616 until it reaches bore distalbore 617, at which point it exits bore 617 and engages the distal end612 of the prosthesis 600 or a trigger wire engagement mechanism 619,such as a suture loop or the like, at the distal end of the prosthesis600 at a distal attachment region 628. The trigger wire 624 may be asingle wire or more than one wire, and preferably three. The distaltrigger wire 624 then re-enters the lumen through bore distal bore 618.

A similar trigger wire system is at the proximal end 614 of theprosthesis 600. One or more proximal trigger wires 626, preferablythree, extend through lumen 616 and through the prosthesis 600 and exitthrough proximal bore 620. The wire or wires then engage the proximalend 614 or a trigger wire engagement mechanism (not shown) at theproximal end 614 of the prosthesis, then re-enter the device throughproximal bore 622. The wire or wires may extend for a length into thenose cone 610.

FIG. 11 shows the proximal end 614 of the delivery device after thetrigger wires have been retracted by the trigger wire retractionmechanism (not shown) and the prosthesis 600 expanded. As shown, theproximal end 614 has a nose cone dilator 610, which has a reverse taper630, inner cannula 608, pusher 606, distal bores 617, 618 and proximalbores 620, 622. The nose cone dilator 610 may have an atraumatic tip611.

FIGS. 12 and 13 show an alternative of (at the distal attachment region)of FIGS. 10 and 11. FIG. 12 shows the distal and proximal trigger wiresin a partial view of the distal end of the delivery system 700, and FIG.13 shows this view without the trigger wires in place. As shown, pusher702 has an inner lumen 704. Distal trigger wire 706, or wires, extendsthrough lumen 704 to distal bore 708 and exits the lumen 704. Triggerwire 706 then engages a distal attachment point 710 on the prosthesis712 and then re-enters lumen through distal bore 709. The prosthesis712, as shown has a distal most stent 714. The distal attachment point710 may be on the stent 714 or on the graft 716. In this embodiment,proximal trigger wire 718, or wires, extends through lumen 704, exitsthrough a distal bore 722 and then extends in the proximal directiontoward the proximal attachment point and operates as described above inconnection with FIGS. 10 and 11. The pusher may have a tapered proximalend 724 as shown. Further, extending through the lumen 704 is an innercannula 726 having a guide wire lumen 728 to accommodate guide wire 730.

The present system eliminates the need for trigger wires to be held inplace by knobs and the deployment steps of manually releasing the knobsand pulling the trigger wires. The system has the further advantage ofproviding a low profile delivery device and the release of the triggerwires in a single step or movement with reduced frictional forces.

Throughout this specification, various indications have been given as topreferred and alternative embodiments of the invention. However, itshould be understood that the invention is not limited to these. It istherefore intended that the foregoing detailed description be regardedas illustrative rather than limiting.

The invention claimed is:
 1. A system for actuating a trigger wire in aprosthesis delivery device, the system comprising: a handle having ahandle proximal end, a handle distal end, and a longitudinal lumenbetween the proximal and distal ends; a rod disposed within thelongitudinal lumen, the rod having a rod proximal end, a rod distal end,a first longitudinal surface with a first engagement mechanism disposedat a first angular orientation between the rod proximal end and the roddistal end, and a second longitudinal surface having a second engagementmechanism disposed at a second angular orientation between the rodproximal end and the rod distal end, wherein the rod is movable from afirst axial position to a second axial position; a wire coiling assemblydisposed within the handle, the wire coiling assembly: comprising afirst rotary gear having a rotation linked to an axial movement of thefirst engagement mechanism, a second rotary gear linked to an axialmovement of the second engagement mechanism, a first wire spool coupledto the rotation of the first rotary gear, the first wire spool windinglyattached to a first trigger wire, and a second wire spool coupled to therotation of second rotary gear, the second wire spool attached to asecond trigger wire.
 2. The system of claim 1, wherein the firstengagement mechanism and second engagement mechanism are axially spacedfrom each other on the rod.
 3. The system of claim 1 wherein the firstengagement mechanism is disposed on a proximal portion of the rod andthe second engagement mechanism is disposed on a distal portion of therod.
 4. The system of claim 3 wherein the first longitudinal surface isdisposed on the rod opposite the second longitudinal surface.
 5. Thesystem of claim 3 wherein the first engagement mechanism and the secondengagement mechanism do not overlap longitudinally.
 6. The system ofclaim 1 wherein the first engagement mechanism is a first geared trackand the second engagement mechanism is a second geared track.
 7. Thesystem of claim 6 wherein the first rotary gear has first gear teeth andthe first wire spool has second gear teeth and wherein the first gearteeth drive the second gear teeth.
 8. The system of claim 7 wherein thefirst rotary gear has a first axis of rotation and the first wire spoolhas a second axis of rotation wherein the first axis of rotation isparallel to the second axis of rotation.
 9. The system of claim 7wherein the first rotary gear has a first axis of rotation and the firstwire spool has a second axis of rotation wherein the first axis ofrotation is at an angle to the second axis of rotation.
 10. The systemof claim 9 wherein the first rotary gear has a first axis of rotationand the first wire spool has a second axis of rotation wherein the firstaxis of rotation is perpendicular to the second axis of rotation. 11.The system of claim 1 wherein the first rotary gear and the first wirespool share a first common axis of rotation, and the second rotary gearand the second wire spool share a second common axis of rotation. 12.The system of claim 1, further comprising a prosthesis having a firstend and a second end, wherein the first trigger wire has a distal endcoupled to the first wire spool and a proximal end releasably attachedto the prosthesis first end, and wherein the second trigger wire has adistal end coupled to the second wire spool and a proximal endreleasably attached to the prosthesis second end.
 13. A system fordelivering an endoluminal prosthesis, the system comprising: a handlehaving a handle proximal end, a handle distal end, and a longitudinalbore; an elongated tubular member having a tubular member proximal end,a tubular member distal end, and at least one lumen between the tubularmember proximal end and the tubular member distal end, the elongatedtubular member being secured to the handle proximal end at the tubularmember distal end; a sheath disposed at the tubular member proximal end,the sheath slidably mounted about the elongated tubular member in alongitudinal direction; an endoluminal prosthesis disposed at thetubular member proximal end, the endoluminal prosthesis being radiallyconstrained by the sheath; a first trigger wire extending from thehandle through the at least one lumen to the proximal end of theelongated tubular member, the first trigger wire coupled to a movementof the sheath; a second trigger wired extending from the handle throughthe at least one lumen to the proximal end of the elongated tubularmember, the second trigger wire retaining the endoluminal prosthesis;and a wire coiling assembly disposed in the distal end of the handle,the wire coiling assembly comprising a rod having a first longitudinalsurface with a first plurality of teeth, a second longitudinal surfacehaving a second plurality of teeth, and a coiling mechanism comprising afirst gear linked to the first plurality of teeth, a second gear linkedto the second plurality of teeth, a first spool securing the firsttrigger wire and coupled to the rotation of the first gear, and a secondspool securing the second trigger wire and coupled to the rotation ofthe second gear.
 14. The system of claim 13 wherein the first pluralityof teeth are disposed proximate a proximal end of the rod, the secondplurality of teeth are disposed proximate a distal end of the rod, andwherein the first plurality of teeth and the second plurality of teethdo not overlap longitudinally.
 15. The system of claim 13 wherein thefirst gear and the first coil have parallel axes of rotation and whereinthe second gear and the second coil have parallel axes of rotation. 16.The system of claim 13 wherein the first gear and the first coil havenon-parallel axes of rotation and wherein the second gear and the secondcoil have non-parallel axes of rotation.
 17. The system of claim 13wherein the first gear, the second gear, the first coil, and the secondcoil each have beveled edges with teeth.